What is cGMP Sterile Filling? The cGMP Sterile Filling area is a specialized cleanroom dedicated to manufacturing sterile materials or processes. Here, sterile drugs are transferred using filling needles into sterile containers, with immediate stoppering or sealing of the containers after filling. These areas encompass GMP Controlled Unclassified Areas, GMP Classified Areas, and GMP Aseptic Processing Areas. Anyone entering these GMP Areas, whether staff, visitors, or contractors, must don protective apparel such as head coverings, face masks, gloves, and full-body gowns (gowning) as needed to safeguard drug products from contamination. Moreover, personnel must adhere to stringent behavioral standards within cleanrooms to minimize microbial contamination. This includes following strict gowning protocols, maintaining high hygiene standards, limiting the number of individuals in sterile suites, and minimizing unnecessary movements. These practices collectively contribute to maintaining the cleanliness and sterility of the cleanroom suites.
For more than 10 years, we have focused on developing, manufacturing, and providing sterile fill/finish services for pharmaceutical and biotechnology products. Our expertise encompasses aseptic filling and terminally sterilized products across a range of finished dosage forms. Aseptic filling, also referred to as sterile filling/finish, is widely recognized as one of the pivotal processes in biopharmaceutical manufacturing, and we specialize in ensuring its precision and efficacy.
Raleigh Molecular is well-equipped to meet your cGMP sterile manufacturing and filling requirements, spanning from clinical development to small-scale commercial batches. We excel in the rapid development and manufacturing of cGMP sterile products while maintaining compliance with current regulatory quality standards. Our approach is flexible and integrated, allowing us to simplify complex sterile processes effectively.
Through our Steriles Made Simple program, we can expedite the manufacturing of your sterile liquid in vials for Phase I/II clinical supplies, typically within a timeframe of about 4 months. We provide a range of readily available vial container closure options and commonly used excipients to ensure the rapid and compliant delivery of clinical materials.
Raleigh Molecular has the capability to work with your API or produce API for you, including sterile API manufacturing if needed. Our formulation experts collaborate with you to develop the appropriate aseptic or sterile vial dosage form by optimizing your existing formulation or creating a new formulation through the use of Design of Experiments (DoE) by our Master formulators.
We manufacture your products in our recently expanded and upgraded sterile suites, which now feature enhanced HEPA systems, RABS aseptic filling line enclosures, vial washing and depyrogenation capabilities, and a newly installed in-house WFI system meeting global sterile manufacturing standards. Our cGMP approved aseptic filling suites maintain a static and operational Grade A (ISO Class 5) environment. Regular monitoring of all areas within our aseptic processing facility, including ancillary support areas, is conducted for viable airborne contamination, viable surface contamination, and non-viable airborne contamination by our on-site QC Microbiology Laboratory. Additionally, our operations are supported by our in-house Analytical Chemistry Laboratory and Quality Assurance Departments.
Raleigh Molecular delivers dependable, secure, and efficient cGMP sterile filling services ranging from preclinical to small-scale commercial batches. Our objective is to expedite the market entry of your sterile injectable products safely and efficiently via our integrated drug development and manufacturing process.
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